Cleared Traditional

PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM

K952292 · Puritan Bennett Corp. · Anesthesiology
Nov 1995
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K952292 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on November 13, 1995, 181 days after receiving the submission on May 16, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K952292 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1995
Decision Date November 13, 1995
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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